Study reference | Population characteristics1 | Study design | Objective | Treatment groups | PRO instruments2(validated, not validated) | Types of PRO instruments (validated only) |
---|---|---|---|---|---|---|
Dabaghzadeh (2013) [7] | No prior EFV treatment experience (n = 51) | RCT (double-blind, placebo-controlled) | To assess the effect of cyproheptadine in prevention of neuropsychiatric adverse adverse drug reactions of ARV regimens containing EFV | 1) ARV therapy (including EFV) + cyproheptadine | BDI-II | Psychiatric symptoms (3) |
HAM-A | ||||||
HAM-D | Depression (2) | |||||
2) ARV therapy (including EFV) + placebo | PANSS | Anxiety (1) | ||||
PANSI | Sleep (1) | |||||
PSQI | ||||||
SCL-90 somatization subscale | ||||||
Bucciardini (2012) [8] | Treatment-experienced patients with treatment failure, resistance, or intolerance with HAART (2 NRTIs + NNRTI or PI) (n = 101) | Prospective, observational study (sub-set of ISS-NIA study) | To evaluate rates and determinants of virological failure in triple-class experienced patients receiving raltegravir-based regimens | 1) All patients received RAL-based therapy; study compared patients with and without virologic failure on RAL | ISSQoL | HRQL: General (1) |
Lake (2012) [9] | HIV-infected women with central adiposity and viral suppression on NNRTI- or PI-based HAART (n = 37) | RCT (open-label) | To evaluate effects of a switch from a PI or NNRTI to RAL on adipose tissue volume and metabolic changes | 1) Immediate switch of PI or NNRTI to RAL (continuing prior NRTI backbone) | CES-D | Depression (1) |
Body Image Impact scale | Psychiatric symptoms (1) | |||||
2) Delayed switch (at 24 weeks) of PI or NNRTI to RAL (continuing prior NRTI backbone) | ||||||
Mosam (2012) [10] | Treatment-naïve patients with HIV-associated Kaposi sarcoma (n = 112) | RCT (open-label) | To compare HRQL between 2 ARV regimens: ZDV/3TC/NFV versus ZDV/3TC/NVP | 1) d4T/3TC/NVP | EORTC QLQ-30 | HRQL: General (1) |
2) d4T/3TC/NVP + chemotherapy | ||||||
Cooper (2011) [11] | Treatment-experienced patients on stable ZDV/3TC/EFV regimen (n = 234) | RCT (open-label) | To assess the effect of switching ZDV/3TC/EFV to TDF/FTC/EFV on adherence, beliefs about ARV therapy and HQRL | 1) Continue ZDV/3TC/EFV twice daily | BMQ-ART | HRQL: General (1) |
HAART Intrusiveness Scale | Medication beliefs: HIV-targeted (2) | |||||
2) Switch to TDF/FTC/EFV once daily | SF-12 (v2) | |||||
Nguyen (2011) [12] | Stable EFV-containing HAART regimen (n = 53) | RCT (double-blind, cross-over) | To investigate the effect of replacing EFV with RAL on patient preference, sleep quality, daytime sleepiness, anxiety, and lipid levels | 1) Continue EFV-containing regimen, then switch EFV to RAL (continuing prior NRTI backbone) | ESS | Sleep (3) |
GSQS | ||||||
SSS | ||||||
2) RAL + prior NRTI backbone, then switch RAL to EFV (continue prior NRTI backbone) | Treatment preference | |||||
Treatment satisfaction | ||||||
Nguyen (2011) [13] | Stable EFV-containing HAART regimen (n = 58) | RCT (double-blind, cross-over) | To investigate the effect of replacing EFV with ETR on patient preference, sleep, anxiety, and lipid levels | 1) EFV-based therapy | ESS | Sleep (3) |
2) ETR-based therapy | SSS | Anxiety/depression/stress (1) | ||||
GSQS | ||||||
DASS21 | ||||||
Treatment preference | ||||||
Treatment satisfaction | ||||||
Campo (2010) [14] | PI-based HAART regimen without history of virological failure (n = 262) | RCT (open-label) | To evaluate the efficacy, safety and PROs of regimen switching to EFV-based HAART | 1) Switch to EFV/3TC/ddI | FAHI | HRQL: HIV (1) |
2) Switch PI to EFV (continuing prior NRTIs) | IIRS | HRQL: General chronic disease (1) | ||||
Treatment preference | ||||||
Treatment satisfaction | ||||||
Cella (2010) [15] | Stable, but virologically failing ARV regimen (n = 1,203) | RCT (pooled analysis of DUET-1 and DUET-2) | To study the effects of etravirine versus placebo on the HRQL of HIV-infected patients | 1) ETR 200 mg twice-daily3 | FAHI | HRQL: HIV (1) |
2) Placebo3 | ||||||
Cooper (2010)] [16] | HIV-infected, treatment-naïve patients (n = 87) | RCT (open-label) | To determine the impact of once-nightly versus twice-daily dosing and beliefs about HAART on adherence to EFV-based HAART in ARV-naïve patients | 1) ddI/3TC/EFV once nightly | BMQ-ART | Medication beliefs: HIV-targeted (2) |
2) AZT/3TC twice daily + EFV nightly | HAART Intrusiveness Scale | |||||
HIV-infected treatment-naïve patients (n = 895) | RCT (double-blind) [MERIT] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) ZDV/3TC + MVC 300 mg twice daily | HIV-SI/SDM | HIV symptoms (1) | |
2) ZDV/3TC + MVC 600 mg once daily | ||||||
3) ZDV/3TC + EFV 600 mg once daily | ||||||
PI- or NNRTI-based ARV regimen with virologic suppression (n = 300) | RCT (open-label) | To evaluate the therapeutic switch to a single-tablet formulation of EFV/FTC/TDF among virologically suppressed, HIV-infected adults | 1) EFV/FTC/TDF | SF-36 (v2) | HRQL: General (1) | |
2) Continue baseline ARVs (PI- or NNRTI-based) | HIV-SI/SDM | HIV symptoms (1) | ||||
Treatmet preference | ||||||
Perceived ease of regimen | ||||||
Potard (2010) [21] | Treatment experienced, NNRTI-naïve (n = 239) | Prospective, observational study | To assess changes in HRQL after switching to an NNRTI-containing regimen | 1) EFV-based therapy | HADS | Anxiety/depression (1) |
2) NVP-based therapy | HIV-SI/SDM | |||||
WHOQOL-HIV | HIV symptoms (1) | |||||
BREF | HRQL: General (2) | |||||
SF-12 (v2) | ||||||
Clifford (2009) [22] | Treatment-naïve; study reports long-term follow-up of patients after unblinding of the AZT/3TC/ABC treatment arm (n = 303) | RCT (secondary analysis of A5095) | To evaluate the long-term impact of EFV-based regimens on neuropsychological performance | 1) AZT/3TC/EFV | CES-D | Depression (1) |
2) AZT/3TC/ABC | PSQI | Sleep (1) | ||||
STAI | Anxiety (1) | |||||
Neuropsychiatric symptoms | ||||||
Gutierrez-Valencia (2009) [23] | Patients scheduled to receive an EFV-containing treatment plus 2 NRTIs (n = 114) | RCT (double-blind) | To determine if starting EFV in a stepwise dose schedule decreases EFV-related neuropsychiatric adverse events while maintaining efficacy | 1) EFV-based therapy (stepwise dosing) | OSQ | Sleep (1) |
2) EFV-based therapy (full dose) | Neuropsychiatric symptoms | |||||
Jayaweera (2009 ) [24] | Treatment-experienced patients (n = 65) | Prospective, single-arm trial (open-label) [DART I] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) ddI/3TC/EFV once-daily | MOS-HIV | HRQL: HIV (1) |
Jayaweera (2009) [24] | Treatment-experienced patients (n = 70) | Prospective, single-arm trial (open-label) [DART II] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) d4T/3TC/EFV once-daily | MOS-HIV | HRQL: HIV (1) |
Boyle (2008) [25] | Treatment-experienced patients on stable twice-daily or more frequent HAART (n = 320) | RCT (open-label) | To evaluate the effect of regimen simplification on maintenance of virologic suppression and treatment adherence | 1) Continue baseline ARVs (BID + dosing) | FAHI | HRQL: HIV (1) |
IIRS | HRQL: General (1) | |||||
2) Switch to once-daily d4T/3TC/EFV | Treatment preference | |||||
Treatment satisfaction | ||||||
DeJesus (2008) [26] | Stable regimen of fixed-dose AZT/3TC with EFV, experiencing AZT/3TC-related adverse effects or who might benefit from a simplified regimen (n = 402) | Prospective, single-arm trial | To evaluate the impact of switching from twice-daily AZT/3TC to once-daily TDF/FTC with EFV) | 1) Switch from twice-daily AZT/3TC to once-daily TDF/FTC with EFV | SF-36 (v2) | HRQL: General (1) |
HIV-SI/SDM | HIV symptoms (1) | |||||
Treatment satisfaction | ||||||
Bucciardini (2007) [27] | Treatment-naïve (n = 139) | RCT (secondary analysis of INITIO-QoL data) | To detect differences in patient’s HRQL among the 3 study treatment groups in the INITIO trial | 1) ddI/d4T/EFV | MOS-HIV | HRQL: HIV (1) |
2) ddI/d4T/NFV | ||||||
3) ddI/d4T/EFV/NFV | ||||||
Lafaurie (2008) [28] | NNRTI-naïve, receiving stable HAART consisting of at least 1 PI, 1 NRTI and AZT (n = 158) | RCT (open-label; secondary analysis of ALIZE data) | To assess if patients who have tolerated long-term AZT regimens will benefit from a switch to EFV/ddI/FTC | 1) Maintenance of stable PI-containing regimen | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily EFV/ddI/FTC | ||||||
Journot (2006) [29] | NNRTI-naïve, receiving unchanged HAART for ≥6 months consisting of at least 1 PI and 2 NRTIs (n = 355) | RCT (open-label; secondary analysis of ALIZE data) | To determine whether EFV use is associated with a higher incidence of depressive disorders compared to PI-containing regimens | 1) Continue PI-based therapy | CES-D | Depression (1) |
2) Switch to EFV-based therapy | ||||||
Portsmouth (2005) [30] | Treatment-experienced patients with virologic suppression receiving d4T/3TC/EFV or ZDV/3TC/EFV (n = 43) | RCT (open-label) | To assess whether virologically controlled HIV-1-infected individuals switched from a twice-daily antiretroviral regimen to a once-daily regimen demonstrate improved adherence and quality of life while maintaining virological control | 1) Continue twice-daily regimen of d4T(IR)/3TC/EFV or ZDV/3TC/EFV | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily d4T(PRC)/3TC/EFV | ||||||
Casado (2004) [31] | Treatment-naïve; subset of patients with HRQL data in original COMBINE trial (n = 127) | RCT (secondary analysis of COMBINE) | To compare HRQL between 2 ARV regimens: ZDV/3TC/NFV versus ZDV/3TC/NVP | 1) ZDV/3TC/NFV | MOS-HIV | HRQL: HIV (1) |
2) ZDV/3TC/NVP | ||||||
Negredo (2004) [32] | HAART experienced patients with long-lasting viral suppression (n = 169) | Prospective, observational study | To explore the long-term safety, and the virological and immunological efficacy of once-daily ddI/TDF/NVP in previously HAART-experienced subjects with long-lasting viral suppression | 1) Continue twice-daily ARV therapy (PI- or NNRTI-based) | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily ddI/TDF/NVP | ||||||
van Leth (2004) [33] | Treatment-naïve; subset of patients with HRQL data in original 2NN clinical trial (n = 917) | RCT (secondary analysis of 2NN data) | To investigate whether these differences in the safety profiles of EFV and NVP translates into differences in HRQL | 1) d4T/3TC/EFV | MOS-HIV | HRQL: HIV (1) |
2) d4T/3TC/NVP | ||||||
3) d4T/3TC/EFV/NVP |